Labelling requirements for supplemented foods

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Overview

Supplemented foods (SFs) are prepackaged foods with one or more added supplemental ingredients (SIs). Supplemented foods sold in Canada are subject to the provisions of the:

The specific requirements and conditions of sales for SFs are set out in Division 29 of the FDR and in 4 documents incorporated by reference (IbR) into the FDR. Additional requirements are also specified in Division 1 and in Part D of the FDR.

When sold intraprovincially, SFs are subject to the labelling requirements under the FDA and FDR, as well as specific requirements of the SFCA and the SFCR that apply to prepackaged foods sold in Canada, regardless of the level of trade. Provincial regulations may also have labelling requirements that apply when these products are sold within that province.

The SF regulations permit the addition of specific vitamins, mineral nutrients, amino acids and other substances to prepackaged products; but this is not regarded as fortification. The SF regulations outline specific rules for SFs in terms of food categories which can be supplemented, composition, labelling and representations. The 4 following documents incorporated by reference in the FDR outline requirements related to labelling requirements for SFs, specific food categories, and SIs and their conditions of use:

Health Canada has prepared a Guidance document: Supplemented Foods Regulations, which elaborates on further details related to SFs. References to relevant sections of Health Canada's guidance document are included on this page.

Refer to the Industry Labelling Tool for additional core labelling and voluntary claims and statements requirements that apply to all prepackaged foods.

List of ingredients

The requirements of the FDR with respect to declaration of ingredients (including SIs), components and allergens apply to the labels of SFs. Refer to the List of ingredients and allergens on food labels for further information.

Supplemented foods as supplemental ingredients

When a SF is used as an ingredient in another SF, the SIs in the first food are also SIs in the second food and not components [B.01.001(4), FDR]. The addition of the SIs to the second food must comply with the conditions set out in the List of permitted supplemental ingredients document incorporated by reference into the FDR. Refer to Direct or indirect addition of supplemental ingredients in the Health Canada Guidance document: Supplemented Foods Regulations for more information.

For example:

For a supplemented cereal bar that contains supplemented chocolate (supplemented with magnesium and vitamin B12) as one of the ingredients, the SIs in the chocolate and any other SIs added to the bar must be declared at the end of the ingredient list in any order:

Ingredients: Oats, Dried Cranberries, Pistachios, Chocolate (sugar, cocoa powder, cocoa butter, lecithin), Honey, Coconut, Magnesium, Vitamin B12

Supplemental ingredients considerations

The List of permitted supplemental ingredients includes all SIs permitted for addition to SFs, along with their conditions of use.

Certain ingredients are not permitted for addition to SFs at any level and further restrictions with respect to the addition of certain SIs may apply. Refer to the following sections of Health Canada's Guidance document: Supplemented Food Regulations:

For further information and examples on SIs and their conditions of use, refer to Supplemental ingredients and their conditions of use in the Health Canada Guidance document: Supplemented Foods Regulations.

Supplemented Food Facts table (SFFt)

Supplemented foods are required to carry a standardized SFFt. The required information, units and manner of expression are found in section B.29.002 and the table to section B.29.002 of the FDR. Supplemented Food Facts table in the Health Canada Guidance document: Supplemented Foods Regulations has more information on the elements within the SFFt.

Refer to Health Canada's Directory of supplemented food facts table formats for acceptable SFFt formats including graphical requirements.

Small packages

With some exceptions, SFs that have an available display surface of under 100 cm2 are not required to carry a SFFt, but the label must contain an indication of how the consumer may obtain the information that would otherwise be shown in the SFFt.

Refer to Small package exemption in the Health Canada Guidance document: Supplemented Foods Regulations for more information as well as the exceptions to this exemption.

Front-of-package nutrition labelling

A front-of-package (FOP) nutrition symbol is mandatory for prepackaged foods that meet or exceed set levels for sodium, sugars or saturated fat [B.01.350, FDR]. Refer to Front-of-package (FOP) nutrition symbol.

Supplemented foods are subject to the same requirements and exemptions for the FOP symbol as other prepackaged foods. This includes a conditional exemption when they are sold in small packages [B.01.350(13.1), FDR]. Refer to Front-of-package nutrition labelling in the Health Canada Guidance document: Supplemented Foods Regulations for more information.

Cautionary statements

Cautionary statements are required on the labels of SFs when they contain certain SIs at any level (such as zinc), or when the SIs they contain are declared above a threshold amount (for example, more than 58 mg of calcium per serving).

Refer to Cautionary statements for supplemental ingredients in the Health Canada Guidance document: Supplemented Foods Regulations for more information on cautionary statements including how to calculate the maximum number of servings when required, and the use and grouping of cautionary statements advising against use by certain population groups.

Specific supplemental ingredients that must have cautionary statement(s) regardless of amount

Certain SIs, such as vitamin A (retinol), zinc, and L-asparagine, among others, are required to carry cautionary statement(s) at any amount declared. For more information, including the specific cautionary statement(s) required, refer to the respective line item in the List of permitted supplemental ingredients.

Supplemented food caution identifier

SFs must carry a Supplemented food caution identifier (SFCI) on their principal display panel when the SF requires one or more cautionary statements on its label [B.29.021, FDR]. Prepackaged products that do not have a list of cautionary statements are prohibited from carrying a SFCI [B.29.024, FDR].

Refer to Supplemented Food Caution Identifier in the Health Canada Guidance document: Supplemented Foods Regulations for more information.

Claims and representations

There are restrictions related to claims for specific SFs when they contain SIs with associated cautionary statements. This includes unique requirements for the use of general nutrient function claims, restriction of certain claims on SFs when the cautionary statement recommends against consumption by a certain age group, and claims on SFs with "high caffeine content" statement. Refer to Claims not permitted for supplemental ingredients with an associated cautionary statement, Claims not permitted on supplemented foods that are not to be consumed by a certain age group, and Claims not permitted on supplemented foods with the "High caffeine content" statement in the Health Canada Guidance document: Supplemented Foods Regulations for more information.

Additional representation exclusions for SFs containing certain SIs can be found in the List of permitted supplemental ingredients. For example, the use of caffeine as a SIs in some categories of SFs excludes those represented for physical performance.

Restrictions on the size of acceptable claims for supplemented foods with a supplemented food caution identifier

There are size restrictions to be aware of on representations, such as claims, when a SF carries a SFCI. Refer to Restrictions on size of acceptable claims for supplemented foods with a supplemented food caution identifier in the Health Canada Guidance document: Supplemented Foods Regulations for more information.

Additional information

Compliance Test

For more information on the compliance test for SIs, please see Implementation plan for amendments to the Food and Drug Regulations (Supplemented Foods).

Related links

Definitions

Supplemented food

Supplemented food means a prepackaged product that belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories and to which a supplemental ingredient has been added, but does not include:

  • a) a food for special dietary use as defined in section B.24.001 and referred to in any of paragraphs B.24.003(1)(f) to (f.2) and (h) to (j), even if the food for special dietary use is also a gluten-free food referred to in paragraph B.24.003(1)(g);
  • a.1) infant food
  • (b) a food that is labelled or advertised for consumption by
    • (i) children one year of age or older but less than four years of age, or
    • (ii) women who are pregnant or breastfeeding;
  • (c) any of the following foods set out in column I of the Table to section D.03.002:
    • (i) a food referred to in any of items 1, 2.1, 2.2, 4, 5, 7, 8, 9.1, 10 to 13, 15, 17 to 19, 21 to 25 and 27, and
    • (ii) prepackaged ice;
  • (d) a food that has not been processed or that has been minimally processed; or
  • (e) a beverage with an alcohol content of more than 0.5%; (aliment supplémenté)

[B.01.001(1), FDR]

Supplemental ingredient

Supplemental ingredient means a nutrient — including a vitamin, mineral nutrient or amino acid — or any other substance listed in column 1 of the List of Permitted Supplemental Ingredients and added as an ingredient to a food in accordance with the applicable conditions of use set out in columns 2 to 5; (ingrédient supplémentaire) [B.01.001(1), FDR]

Supplemented food caution identifier

Supplemented food caution identifier means the identifier carried on the principal display panel of a supplemented food under subsection B.29.021(1); (identifiant des aliments supplémentés avec mise en garde) [B.01.001(1), FDR]

Supplemented food facts table

Supplemented food facts table means the supplemented food facts table required by subsection B.29.002(1) to be carried on the label of a supplemented food; (tableau des renseignements sur les aliments supplémentés) [B.01.001(1), FDR]

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